Advanced Solid TumorsPhase 1NCT00908908
A Study to Determine the Metabolism and Elimination of Carbon-14 Labeled Eribulin Acetate (14C-Eribulin) in Patients With Advanced Solid Tumors
A Phase 1 study testing eribulin in people with Advanced Solid Tumors, run by Eisai Inc. at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine the metabolism and elimination of carbon-14 labeled eribulin acetate (14C-eribulin) in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- eribulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2009to May 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a histologically or cytologically confirmed advanced solid tumor that has progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy). Patients with measurable tumors according to RECIST are desirable but not essential.
- Patients must be aged 18 years or older.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1, or 2.
- Patients must have adequate renal function as evidenced by serum creatinine ≤135 µM/L (≤1.5 mg/dL) or creatinine clearance >= 40 mL/minute (min).
- Patients must have adequate bone marrow function as evidenced by absolute neutrophil count (ANC) >= 1.5 x 10^9/L and platelet count >= 100 x 10^9/L.
- Patients must have adequate hepatic function as evidenced by bilirubin ≤ 1.5 times the upper limit of normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 3 x ULN (in the case of liver metastases ≤ 5 x ULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.
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- Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or below, except for stable sensory neuropathy ≤ Grade 2 and alopecia.
- Patients must be willing and able to comply with the study protocol for the duration of the study.
- Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
Who cannot join
- Patients who have received any of the following treatments within the specified period before treatment start:
- chemotherapy, radiation, or biological therapy within three weeks
- hormonal therapy within one week
- any investigational drug within 4 weeks
- systemic unconventional or alternative therapies including, but not limited to, herbal remedies within 4 weeks
- Have had radiation therapy encompassing > 30% of marrow.
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- Have received prior treatment with mitomycin C or nitrosourea.
- Have had major surgery within 4 weeks before starting study treatment
- Patients with pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
- Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (e.g., radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks.
- Patients with meningeal carcinomatosis.
- Patients who are receiving anti-coagulant therapy with warfarin or related compounds, other than for line patency, and cannot be changed to heparin-based therapy, are not eligible. If a patient is to continue on mini-dose warfarin, then the prothrombin time (PT) or international normalized ratio (INR) must be closely monitored.
- Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Peri-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Patients with severe/uncontrolled intercurrent illness/infection.
- Significant cardiovascular impairment (history of congestive heart failure > New York Heart Association (NYHA) grade II, unstable angina or myocardial infarction within the past 6 months, or serious cardiac arrhythmia).
- Patients with organ allografts requiring immunosuppression.
- Patients with known positive HIV status.
- Patients with pre-existing neuropathy > Grade 2.
- Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.
- Patients who participated in a prior eribulin clinical trial, whether or not they received eribulin (E7389).
- Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Non-Randomized, Single-Center Study to Determine the Metabolism and Elimination of Carbon-14 Labeled Eribulin Acetate (14C-Eribulin) in Patients With Advanced Solid Tumors
The purpose of this study is to determine the metabolism and elimination of carbon-14 labeled eribulin acetate (14C-eribulin) in patients with advanced solid tumors.
Read the detailed description
The study will be conducted in two phases, the initial Study phase to administer the radio-labeled 14C-eribulin and collection of PK samples, and the Extension Phase when the patients will continue to receive non-radio-labeled eribulin. In the initial Study phase, patients will receive a single 2 mg flat dose of 14C-eribulin (approximately 80 to 90 microCuries) administered on Cycle 1 Day 1 as an intravenous (IV) bolus injection or infusion over 2-5 minutes. Following this initial dose, patients will remain in the research unit until Day 8 to complete sample collections of urine, blood and feces for PK analysis and determination of 14C-eribulin concentrations between Days 1 and 8.
On Day 8 patients will be re-assessed and discharged, and return on day 15 for physical exam, adverse event evaluation, and lab tests. The patients will then enter the Extension Phase of the study and continue to receive on-radio-labeled eribulin at a dose of 1.4 mg/m^2 on Days 1 and 8 of every 21 day cycle.
- Conditions
- Advanced Solid Tumors
- Being tested
- eribulin
- Keywords
- Advanced Solid Tumors, Failure of Multiple Prior Chemotherapy Regimens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eribulinDrug
Also called E7389
Cycle 1 day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on days 1 and 8 every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: eribulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excretion Balance of Radio-labeled 14C-eribulin: Total Recovery of Radioactive Dose in Urine and Feces.
Measured: 312 hours postdose
Pharmacokinetics: AUC (0-t) for Total Radioactivity in Plasma
Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring total radioactivity exposure.
Measured: Between Days 1 and 8 of Cycle 1
Pharmacokinetics AUC (0-t) for Eribulin in Plasma
Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring exposure to eribulin.
Measured: Between Days 1 and 8 of Cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Koetz, MSc, Study director, Eisai Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908908
- Sponsor's protocol ID
- E7389-E044-103
- Status last verified
- Mar 2012
- First submitted
- 20 May 2009
- Last updated
- 9 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Non-Randomized, Single-Center Study to Determine the Metabolism and Elimination of Carbon-14 Labeled Eribulin Acetate (14C-Eribulin) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00908908
- Acronym / sponsor ID
- E7389-E044-103
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced Solid Tumors, Failure of Multiple Prior Chemotherapy Regimens
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 May 2009 (estimated)
- Results
- Posted 27 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the metabolism and elimination of carbon-14 labeled eribulin acetate (14C-eribulin) in patients with advanced solid tumors.
Detailed description
The study will be conducted in two phases, the initial Study phase to administer the radio-labeled 14C-eribulin and collection of PK samples, and the Extension Phase when the patients will continue to receive non-radio-labeled eribulin. In the initial Study phase, patients will receive a single 2 mg flat dose of 14C-eribulin (approximately 80 to 90 microCuries) administered on Cycle 1 Day 1 as an intravenous (IV) bolus injection or infusion over 2-5 minutes. Following this initial dose, patients will remain in the research unit until Day 8 to complete sample collections of urine, blood and feces for PK analysis and determination of 14C-eribulin concentrations between Days 1 and 8.
On Day 8 patients will be re-assessed and discharged, and return on day 15 for physical exam, adverse event evaluation, and lab tests. The patients will then enter the Extension Phase of the study and continue to receive on-radio-labeled eribulin at a dose of 1.4 mg/m^2 on Days 1 and 8 of every 21 day cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: eribulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have a histologically or cytologically confirmed advanced solid tumor that has progressed following standard therapy or for which no standard therapy exists (including surgery or radiation therapy). Patients with measurable tumors according to RECIST are desirable but not essential.
- Patients must be aged 18 years or older.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1, or 2.
- Patients must have adequate renal function as evidenced by serum creatinine ≤135 µM/L (≤1.5 mg/dL) or creatinine clearance >= 40 mL/minute (min).
- Patients must have adequate bone marrow function as evidenced by absolute neutrophil count (ANC) >= 1.5 x 10^9/L and platelet count >= 100 x 10^9/L.
Key exclusion criteria (21 listed)
- Patients who have received any of the following treatments within the specified period before treatment start:
- Have had radiation therapy encompassing > 30% of marrow.
- Have received prior treatment with mitomycin C or nitrosourea.
- Have had major surgery within 4 weeks before starting study treatment
- Patients with pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eribulinAlso: E7389Cycle 1 day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on days 1 and 8 every 21 days. | Drug | 1 |
Primary outcome
Excretion Balance of Radio-labeled 14C-eribulin: Total Recovery of Radioactive Dose in Urine and Feces.
Time frame: 312 hours postdose
Pharmacokinetics: AUC (0-t) for Total Radioactivity in Plasma
Time frame: Between Days 1 and 8 of Cycle 1
Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring total radioactivity exposure.
Pharmacokinetics AUC (0-t) for Eribulin in Plasma
Time frame: Between Days 1 and 8 of Cycle 1
Area under the plasma concentration-time curve from time zero to last quantifiable plasma concentration measuring exposure to eribulin.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Koetz, MSc study director
Eisai Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing eribulin in people with Advanced Solid Tumors, run by Eisai Inc. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excretion Balance of Radio-labeled 14C-eribulin: Total Recovery of Radioactive Dose in Urine and Feces. (time frame: 312 hours postdose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2012.